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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-002120-14
    Sponsor's Protocol Code Number:3074K4-2207-WW
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-002120-14
    A.3Full title of the trial
    A Multicenter, Open-Label, Ascending Multiple-Dose Study to Assess the
    Pharmacokinetics, Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age With Selected Serious Infections
    A.4.1Sponsor's protocol code number3074K4-2207-WW
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research Division of Wyeth Pharmaceutical Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tygacil 50mg Powder for solution for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTygacil
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTigecycline
    D.3.9.1CAS number 220620-09-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), community-acquired pneumonia (CAP).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10056570
    E.1.2Term Intra-abdominal infection
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10040872
    E.1.2Term Skin infection
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections (cIAI, cSSSI, CAP).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female patients aged 8 to 11 years, inclusive.
    2) Willing and able to complete all activities required for the study.
    3) Anticipated length of antibiotic therapy ≥ 5 days.
    4) Have a diagnosis of a serious infection (eg, cIAI, cSSSI, or CAP) requiring hospitalization and administration of IV antibiotic therapy.
    5) Specific criteria must also be satisfied for each specific sites of infection.
    (a) For patients with cIAI:
    · Be scheduled for or (within 48 hours before screening) have undergone a laparotomy, laparoscopy, or transrectal or percutaneous drainage of an intra-abdominal abscess.
    · Have a cIAI such as the following:
    - appendicitis complicated by perforation (grossly visible) and/or abscess;
    - purulent peritonitis or peritonitis associated with fecal contamination;
    - intra-abdominal abscess;
    - viscus perforation with symptoms lasting at least 12 hours before operation.
    · Have at least 2 of the following signs and symptoms:
    - abdominal tenderness or pain;
    - abdominal mass on physical examination;
    - ileus or hypoactive bowel sounds;
    - severe nausea and/or vomiting
    - evidence or suspicion of an intra-abdominal abscess or viscus perforation by radiography, scintigraphy, ultrasonography, computed tomography (CT), or magnetic resonance imaging (MRI)
    (b) For patients with cSSSI:
    · Have a cSSSI requiring significant surgical intervention or involving deeper soft tissue. This would include clinical entities such as the following:
    - infected ulcers or wounds that have developed signs of erythema, swelling, fluctuance, tenderness, pus, or warmth;
    - burns (< 20% body surface area, nonfull-thickness);
    - major abscess (not treatable through surgery alone);
    - deep or extensive cellulitis, either in an underlying disease state or > 10 cm in width or length (where anatomically applicable);
    - peripheral IV catheter sites with documented purulent drainage, provided that the catheter line will be removed;
    - infected human or animal bites.
    · Have at least 2 of the following signs and symptoms:
    - drainage and/or discharge;
    - erythema;
    - swelling and/or induration and/or fluctuance;
    - localized warmth;
    - pain and/or tenderness to palpation.
    (c) For patients with CAP:
    · Suspected bacterial rather than viral pneumonia.
    · Chest radiograph (posteroanterior/anteroposterior and if possible lateral views) within 48 hours before the first administration of IV test article showing the presence of an infiltrate.
    · Presence of at least 2 of the following:
    - dyspnea or tachypnea (respiratory rate > 30 breaths per minute);
    - cough;
    - production of purulent sputum or a change in sputum character consistent with bacterial infection;
    - auscultatory findings of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds or egophony);
    - hypoxemia with partial pressure of oxygen (PO2) < 60 mm Hg or oxygen saturation < 90% while the patient is breathing room air, as determined by pulse oximetry or arterial blood gas (ABG);
    - leukocytosis (white blood cell count [WBC] > 13 × 109/L [13,000/mm3]); OR > 15% immature neutrophils (bands); OR leukopenia with total WBC < 4.5 × 109/L (4,500/mm3).
    · The presence of either of the following:
    - fever (within the 24 hours before “randomization”/enrollment), defined as a rectal/core temperature > 38°C/100.4°F, oral temperature > 37.5°C/99.5°F, or axillary temperature > 37.2°C/99°F OR hypothermia, defined as rectal/core body temperature < 35°C/95°F
    E.4Principal exclusion criteria
    1) Patients with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of safety or efficacy responses or make it unlikely that the anticipated course of therapy or follow-up assessment will be completed (eg, life expectancy < 30 days).
    2) For cSSSI patients, the presence of decubitus ulcers, necrotizing fasciitis, gas gangrene, or skeletal infection.
    3) Endocarditis; presence of an artificial heart valve or infected device that will not be removed.
    4) CAP patients who have been hospitalized within 14 days before the onset of symptoms.
    5) Patients with any of the following conditions:
    - Cystic fibrosis.
    - Active tuberculosis.
    - Congenital immunodeficiency.
    - Meningitis.
    - Septic shock.
    - Osteomyelitis (suspected or evident).
    - Refractory shock syndrome in which hemodynamic parameters cannot be maintained despite adequate supportive therapy.
    - Confirmed malignancy with patient receiving an active course of chemotherapeutic agents.
    - Known or suspected infection with human immunodeficiency virus (HIV) or positive test result for HIV antibody.
    - Known or suspected concomitant bacterial or parasitic infection requiring systemic treatment.
    6) Presence of any of the following for patients with pneumonia:
    - Postobstructive pneumonia.
    - Pulmonary abscess.
    - Empyema.
    - Known or suspected pulmonary infection with Pneumocystis carinii.
    7) Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (ie, tetracyclines).
    8) Known or suspected P. aeruginosa infection.
    9) Patients receiving immunosuppressive therapy that, in the opinion of the investigator, would decrease the patient’s ability to eradicate the infection, including the use of high-dose corticosteroids (eg, chronic [for ≥ 3 weeks before “randomization”/enrollment] use of > 10 mg of prednisone adult equivalent per day).
    10) Receipt of an organ or bone marrow transplant.
    11) Presence of any of the following laboratory findings:
    - Neutropenia (absolute neutrophil count < 1 × 109/L [< 1000/mm3]).
    - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 10 × the upper limit of normal (ULN) or bilirubin > 3 × ULN, unless isolated hyperbilirubinemia is directly related to the acute process (for patients with cIAI).
    12) Pregnant or breastfeeding female patients and female patients of childbearing potential (ie, female patients are either biologically capable of becoming pregnant or have started their menses) who are unable or unwilling to take adequate contraceptive precautions.
    13) Previous participation in this clinical trial.
    14) Receipt any investigational drugs or devices (defined as lacking regulatory agency within 4 weeks before administration of the first dose of tigecycline.
    E.5 End points
    E.5.1Primary end point(s)
    No Primary Endpoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 72
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
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